Shenzhen Roundwhale Technology Co. , Ltd. · Class II · Cleared Jan 11, 2024
| K-number | K232995 |
| Device name | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe |
| Applicant | Shenzhen Roundwhale Technology Co. , Ltd. |
| Product code | GXY |
| Device class | Class II |
| Decision date | Jan 11, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 882.1320 |
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